Biomarker of improved intestinal function

a biomarker and intestinal function technology, applied in the field of intestinal function biomarkers, can solve the problems of not always the case, each suffers from potential bias, and is less sensitive than desired for small changes

Inactive Publication Date: 2007-08-09
NPS PHARM INC
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Problems solved by technology

All of these measures have a quantitative component, yet each suffers from potential bias due to the lack of specificity in describing the overall adaptive process in the intestine.
Gross pathology, such as tissue weight and length, are dependent upon an unknown starting point for a given animal, do not specifically address function, and are less sensitive than desired for small changes.
Transporter assays and DNA content evaluate only portions of the intestine, and do not capture the complete role of the organ.
In most cases several of these measures are implemented in a study to describe the adaptive process because a single measure is insufficient.
Although logical, this is not alway

Method used

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Embodiment Construction

[0019] The intestinal adaptation process has been studied intensively for over 100 years, yet, even today, the tools used to characterize the adaptive process are complicated and potentially biased. One well-established model system used to study intestinal adaptation is that of small bowel resection in rats. The time course of the adaptive process in rats is well characterized in this model, with complete adaptation occurring within 30 days following intestinal resection (Dowling and Booth, 1967; Hanson et al., 1977). These estimates have been obtained using invasive techniques that require multiple animals to be sacrificed at each time point, denying the opportunity to observe the progression of an individual animal. Furthermore, these invasive techniques are inappropriate for a clinical study.

[0020] For the first time, a pharmacodynamic model of plasma citrulline as a marker for intestinal function and adaptation has been developed. The exponential growth model was fit to plasma...

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Abstract

The invention disclosed herein demonstrates that that the adaptive process in the intestine can be tracked using plasma citrulline. It further demonstrates that plasma citrulline is of clinical utility as a biomarker for improvements in intestinal function.

Description

CROSS-REFERENCE TO RELATED APPLICATION [0001] This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 60 / 741,074 filed on Dec. 1, 2005, the entire contents of which are hereby incorporated by reference.FIELD OF THE INVENTION [0002] The present invention relates to a biomarker of intestinal function and to the use of the biomarker in the monitoring of improvements in intestinal function and in the monitoring of the adaptive response of the intestine as a result of drug treatment or other therapy. BACKGROUND OF THE INVENTION [0003] Glucagon-like peptide 2 (GLP-2), a 33-amino acid peptide that arises from tissue specific processing of the glucagon precursor, proglucagon, within the mucosal L-cells of both the small and large bowel and the specific neurons located in the brain stem (Drucker, 2002, Gut.50:428-435; Burrin et al., 2003, Domest. Anim Endocrinol. 24:103-122,). GLP-2 is co-secreted with GLP-1 from the intestinal enteroendocrine L-cells, w...

Claims

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Application Information

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IPC IPC(8): G01N33/00
CPCA61K38/26G01N2800/52G01N2800/065G01N33/6812
Inventor TEUSCHER, NATHAN S.DEMCHYSHYN, LIDIA L.WELLS, DAVID S.
Owner NPS PHARM INC
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